BACKGROUND Tissues from cadaveric donors are used in several clinical circumstances, and the transmission of infectious diseases has been reported. Cadaveric donor (CD) blood sample analysis is challenging due to its poor quality. However, studies have demonstrated the usefulness of molecular based methods, and the lack of studies using available commercial molecular tests was reported. OBJECTIVE The aim of this study was to evaluate the performance, specificity, sensitivity, and accuracy of different commercial molecular tests for HIV and HCV detection and quantification in CD through spiked samples. STUDY DESIGN 20 CD and 20 blood donor samples were tested using 1,000 copies/mL and 1,000 IU/mL of lyophilized standards of HIV and HCV, respectively. Samples were analyzed by different molecular kits: XPERT HCV Viral Load and HIV-1 (Cepheid), COBAS® TaqMan® HIV-1 and COBAS® TaqMan® HCV Test, v2.0 (Roche), and artus® HI Virus-1 QS-RGQ and artus® HCV RG RT-PCR Kit (Qiagen). RESULTS HIV and HCV in CD were detected by RT-PCR-based quantitative kits. The tests performed by the Cepheid and the Roche kits showed the most accurate, sensitive and specific results, however, a wide variability between the assays and kits was observed. The Qiagen kits did not demonstrate satisfactory results. CONCLUSIONS CD evaluation showed great variability. The Cepheid and Roche kits were more sensitive for detecting HIV on CD and Cepheid was the most efficient kit for HCV quantification in CD. The Roche and Cepheid kits can be used to screen tissue donors for HIV and HCV.

中文翻译：

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使用不同的分子检测方法检测和定量尸体组织供体中的人类免疫缺陷病毒和丙型肝炎病毒。

背景技术尸体供体的组织被用于几种临床情况，并且已经报道了传染病的传播。尸体供体（CD）血样分析质量差，因此具有挑战性。然而，研究证明了基于分子的方法的有用性，并且据报道缺乏使用可用的商业分子测试的研究。目的本研究的目的是评估通过加标样品对CD中的HIV和HCV进行检测和定量的各种商业分子检测的性能，特异性，敏感性和准确性。研究设计分别使用1,000份/ mL和1,000 IU / mL的HIV和HCV冻干标准品测试了20个CD和20个献血者样品。通过不同的分子试剂盒分析了样品：XPERT HCV病毒载量和HIV-1（造父变星），COBAS®TaqMan®HIV-1和COBAS®TaqMan®HCV Test，v2.0（Roche）以及artus®HI Virus-1 QS-RGQ和artus®HCV RG RT-PCR试剂盒（Qiagen）。结果通过基于RT-PCR的定量试剂盒检测到CD中的HIV和HCV。造父变星和Roche试剂盒进行的测试显示了最准确，灵敏和特异的结果，但是，观察到的检测方法和试剂盒之间存在很大差异。Qiagen试剂盒未显示令人满意的结果。结论CD评估显示出很大的变异性。Cepheid和Roche试剂盒对于检测CD上的HIV更敏感，而Cepheid是CD上HCV定量最有效的试剂盒。Roche和Cepheid试剂盒可用于筛查组织供体的HIV和HCV。结果通过基于RT-PCR的定量试剂盒检测到CD中的HIV和HCV。造父变星和罗氏试剂盒进行的测试显示了最准确，灵敏和特异的结果，但是，观察到的方法和试剂盒之间存在很大差异。Qiagen试剂盒未显示令人满意的结果。结论CD评估显示出很大的变异性。Cepheid和Roche试剂盒对于检测CD上的HIV更敏感，而Cepheid是CD上HCV定量最有效的试剂盒。Roche和Cepheid试剂盒可用于筛查组织供体的HIV和HCV。结果通过基于RT-PCR的定量试剂盒检测到CD中的HIV和HCV。造父变星和罗氏试剂盒进行的测试显示了最准确，灵敏和特异的结果，但是，观察到的方法和试剂盒之间存在很大差异。Qiagen试剂盒未显示令人满意的结果。结论CD评估显示出很大的变异性。Cepheid和Roche试剂盒对于检测CD上的HIV更敏感，而Cepheid是CD上HCV定量最有效的试剂盒。Roche和Cepheid试剂盒可用于筛查组织供体的HIV和HCV。Qiagen试剂盒未显示令人满意的结果。结论CD评估显示出很大的变异性。Cepheid和Roche试剂盒对于检测CD上的HIV更敏感，而Cepheid是CD上HCV定量最有效的试剂盒。Roche和Cepheid试剂盒可用于筛查组织供体的HIV和HCV。Qiagen试剂盒未显示令人满意的结果。结论CD评估显示出很大的变异性。Cepheid和Roche试剂盒对于检测CD上的HIV更敏感，而Cepheid是CD上HCV定量最有效的试剂盒。Roche和Cepheid试剂盒可用于筛查组织供体的HIV和HCV。